GUEST COLUMNISTS

• CDER Wants Your Input On Improving Integrated Reviews

  CDER recently moved from sharing reviews from individual disciplines in public documents to an Integrated Review, which includes conclusions but much less detail.

• Are You Considering Serialization Processes When Choosing Your CDMO Or 3PL?

  When choosing your trading partner (CDMO or 3PL), an important element that can be overlooked is serialization and DSCSA compliance. Ensuring these partners can meet requirements is critical.

• 3 AI Breakthroughs Revolutionizing Pharma Tech Ops At Roche

  Roche has pushed through so-called "pilot purgatory" and rolled out artificial intelligence solutions in the real world. Two of its data leaders describe three case studies.

• What's In The Leukopak Matters For Cell Therapy Manufacturing

  Advanced cell-based therapies are impossible without high-quality leukopaks from high-quality donors.

• Survey Says Downstream Biomanufacturing Bottleneck Is Over

  BioPlan's 21st annual survey finds that downstream processing capacity constraints are at their lowest reported in years.

• The Regulatory Affairs Function Is Evolving. Are You Evolving With It?

  The regulatory affairs function is no longer a "one size fits all" function, the decision to outsource or insource the function is growing more complex, and specific AI tools can help regulatory processes.

• Computer Systems Validation Pitfalls, Part 1: Methodology Violations

  When computer systems validation work is not performed according to protocol instructions — by cutting corners on quality outputs with the focus on profit as the main driver — this can result in drug and device companies losing profits and efficiencies.

• Enhanced Risk? EMA Issues New Guidance For OSD Co-processed Excipients

  In recent years, there has been a drive toward the use of co-processed excipients to aid leaner manufacturing. This has prompted the European Medicines Agency (EMA) to develop a new guidance document, Questions and Answers regarding co-processed excipients used in solid oral dosage forms (H & V). The public consultation period is open until the end of 2024.